The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-7
SponsorAssiut University

About this trial

This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective tonsillectomy operation

pediaterics between ( 4 : 7 ) years old

ASA I OR II

Disqualifiers

emergency cases as bleeding tonsills

ASA III OR IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propofol

    Drug

    In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus

  • Lidocaine %2 ampoule

    Drug

    In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Group ( p ) recieve 1mg /kg of propofolActive comparator 1 intervention
Group B: Group ( L ) recieve 1.5 mg/kg of lidocaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.

Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

Time frame
Within 30 minutes after extubation
2

To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale

Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).

Time frame
Within 30 minutes after extubation.

Secondary outcomes

1

emergence time from anesthesia

Time frame
Within 30 minutes after extubation.
2

peaked PAED scores

Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

Time frame
Within 30 minutes after extubation.
3

extubation time

Time frame
Within 30 minutes after extubation.
4

post-operative pain using FLACC score

The FLACC scale is used to assess postoperative pain in children. It consists of 5 categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, giving a total score range of 0-10.

Time frame
Within 30 minutes after extubation.

Other outcomes

Sponsors and contacts

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